Trials / Completed
CompletedNCT00019656
Perifosine in Treating Patients With Refractory Solid Tumors or Hematologic Cancer
A Phase I Trial of Oral Perifosine With Different Loading Schedules in Patients With Refractory Neoplasms
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have refractory solid tumors or hematologic cancer.
Detailed description
OBJECTIVES: * Determine the dose-limiting toxicity and maximum tolerated dose of perifosine administered as a varying series of loading and maintenance doses in patients with refractory solid tumors, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, myelodysplastic syndromes, or Hodgkin's lymphoma. * Determine the profile of adverse reactions (including changes in laboratory parameters) in patients treated with this regimen. * Determine any disease responses that may occur in patients treated with this regimen. * Determine the steady-state pharmacology and pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive a loading dose of oral perifosine on day 1 followed by a maintenance dose 2-3 times daily beginning on day 2 or 3 and continuing until day 21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating loading and maintenance doses of perifosine until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients are treated at that dose level. Patients are followed every 3 months. PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-18 months.
Conditions
- Leukemia
- Lymphoma
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasms
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | perifosine |
Timeline
- Start date
- 1999-08-01
- First posted
- 2003-01-27
- Last updated
- 2015-04-29
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00019656. Inclusion in this directory is not an endorsement.